Identifying the best dose of lisinopril to reduce high blood pressure in children who have received a kidney transplant.
This study examined the pharmacokinetics of lisinopril in pediatric kidney transplant recipients. The study enrolled approximately 28 children aged 2-17 years who had stable allograft function and needed medication therapy to control high blood pressure. The study was open to children of both sexes and all racial and ethnic groups. Each child participated in the study for up to 51 days (including 7 days of screening, 14 days of drug administration, and 30 days of safety monitoring).
Uptal Patel, MD, of Duke Clinical Research Institute, discusses the lisinopril in pediatric kidney transplant recipients study.
Summary
Lisinopril is approved by the U.S. Food and Drug Administration for the treatment of high blood pressure (hypertension) in adults and children aged 6+ years. However, the appropriate dose of lisinopril in children below the age of 6 was not well known. In addition, high blood pressure is common among children and adolescents who have received a kidney transplant, but the appropriate dose of lisinopril in this vulnerable group was also unknown.
We administered lisinopril to children and adolescents with high blood pressure who had received a kidney transplant. The levels of lisinopril in each person were measured, thereby allowing the determination of the best dose of lisinopril to reduce high blood pressure in this fragile population.
Publications
- Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose SelectionClinical Pharmacology Therapy • July 2015 Access article on PubMed. Trachtman H, Frymoyer A, Lewandowski A, Greenbaum LA, Feig DI, Gipson DS, Warady BA, Goebel JW, Schwartz GJ, Lewis K, Anand R, Patel UD; Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee. Hypertension in pediatric kidney transplant recipients contributes to long-term graft loss, yet treatment options–including ...
OVERVIEW
Status:
Completed, label changed
ClinicalTrials.gov identifier:
NCT01491919
Principal Investigators:
Howard Trachtman, MD
New York University Langone Medical Center
New Hyde Park, NY
Uptal Patel, MD
Duke Health, Durham, NC
Label Change
When researchers compared how much lisinopril the body is exposed to (after adjusting for dose) in children with kidney transplants and without, the levels were similar. The label now indicates that having a kidney transplant did not change how lisinopril is processed.
NEWS
- The PTN lisinopril study to begin enrolling patients in April 2012A study to determine the safety and pharmacokinetics of lisinopril in children and adolescents receiving kidney transplants will begin enrolling participants in April 2012. Lisinopril is approved by the U.S. Food and Drug Administration for the treatment of children aged 6 years and older and adults with high blood pressure, heart failure, and heart attack. High ...